A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK424887 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin- Receceptor Occupancy
Overview
- Phase
- Phase 1
- Intervention
- GSK424887
- Conditions
- Depressive Disorder and Anxiety Disorders
- Sponsor
- GlaxoSmithKline
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males aged 18-45 years, limited to 25-40 years for PET section
Exclusion Criteria
- •The subject has a positive: drug/alcohol, Hepatitis, HIV screen
- •The subject has a history of psychiatric illness suicidal attempts or behaviour.
- •Abuse of alcohol.
- •Clinically significant laboratory, ECG abnormality;
- •The subject has recently received an investigational.
- •Use of prescription or non-prescription drugs,
- •History or presence of allergy to the study drug or drugs of this class,.
- •Donation of more than 500 mL blood within the 90 days before dosing.
- •An unwillingness of male subjects to comply with contraceptive requirements
- •Average daily caffeine intake exceeding Protocol requirements.
Arms & Interventions
Active
GSK424887 once daily
Intervention: GSK424887
Active
GSK424887 once daily
Intervention: PET
Placebo
Placebo once daily
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax
Time Frame: 12 weeks
Secondary Outcomes
- Brain receptor occupancy(2 weeks)